Soumitri Barua; Robert Greenwald, JD; Jason Grebely, PhD; Gregory J. Dore, MBBS, PhD; Tracy Swan; Lynn E. Taylor, MD
Note: Dr. Taylor and Mr. Greenwald had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. Dr. Taylor affirms that she has listed everyone who contributed significantly to the work. There was no involvement of any pharmaceutical company or commercial entity in the preparation of this work.
Disclaimer: The views expressed in this publication do not necessarily represent the position of the Australian government. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institute of Allergy and Infectious Diseases or the National Institutes of Health.
Acknowledgment: The authors thank Evan Cunningham (The Kirby Institute, University of New South Wales, Sydney, Australia) for his assistance with preparing the figures for this manuscript; Amy Rosenberg (Center for Health Law and Policy Innovation, Harvard Law School, Cambridge, Massachusetts) for her suggested edits; and Kellen Wittkop and Sam Hammond (Center for Health Law and Policy Innovation, Harvard Law School, Cambridge, Massachusetts) for assistance with data collection.
Financial Support: The Kirby Institute is funded by the Australian Government Department of Health and Ageing. Dr. Grebely is supported by a National Health and Medical Research Council Career Development Fellowship. Mr. Greenwald is supported by Harvard Law School. Dr. Taylor is supported by a Rhode Island Innovation Fellowship from the Rhode Island Foundation for her “Rhode Island Defeats Hep C” project and the Lifespan/Tufts/Brown Center for AIDS Research (grant P30AI042853 from the National Institute of Allergy and Infectious Diseases). Ms. Barua was supported by the Lifespan/Tufts/Brown Center for AIDS Research Summer Student Internship program (grant P30AI042853).
Disclosures: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M15-0406.
Editors' Disclosures: Christine Laine, MD, MPH, Editor in Chief, reports that she has no financial relationships or interests to disclose. Darren B. Taichman, MD, PhD, Executive Deputy Editor, reports that he has no financial relationships or interests to disclose. Cynthia D. Mulrow, MD, MSc, Senior Deputy Editor, reports that she has no relationships or interests to disclose. Deborah Cotton, MD, MPH, Deputy Editor, reports that she has no financial relationships or interest to disclose. Jaya K. Rao, MD, MHS, Deputy Editor, reports that she has stock holdings/options in Eli Lilly and Pfizer. Sankey V. Williams, MD, Deputy Editor, reports that he has no financial relationships or interests to disclose. Catharine B. Stack, PhD, MS, Deputy Editor for Statistics, reports that she has stock holdings in Pfizer.
Requests for Single Reprints: Lynn E. Taylor, MD, Department of Medicine, Division of Infection Diseases, The Warren Alpert Medical School of Brown University, The Miriam Hospital, 164 Summit Avenue, Center for AIDS Research Building, Room 156, Providence, RI; e-mail, LTaylor@Lifespan.org.
Current Author Addresses: Ms. Barua: Brown University, 69 Brown Street, Box 2222, Providence, RI 02912.
Mr. Greenwald: Center for Health Law and Policy Innovation, Harvard Law School, 122 Boylston Street, Jamaica Plain, MA 02130.
Drs. Grebely and Dore: The Kirby Institute, University of New South Wales, Wallace Wurth Building, Sydney New South Wales 2052, Australia.
Ms. Swan: Treatment Action Group, 611 Broadway, Suite 308, New York, NY 10012.
Dr. Taylor: Department of Medicine, Division of Infectious Diseases, The Warren Alpert Medical School of Brown University, The Miriam Hospital, 164 Summit Avenue, Center for AIDS Research Building, Room 156, Providence, RI 02906.
Author Contributions: Conception and design: J. Grebely, L.E. Taylor.
Analysis and interpretation of the data: S. Barua, R. Greenwald, J. Grebely, G.J. Dore, T. Swan, L.E. Taylor.
Drafting of the article: S. Barua, R. Greenwald, J. Grebely, T. Swan, L.E. Taylor.
Critical revision of the article for important intellectual content: J. Grebely, G.J. Dore, Swan T, L.E. Taylor.
Final approval of the article: S. Barua, R. Greenwald, J. Grebely, G.J. Dore, T. Swan, L.E. Taylor.
Statistical expertise: S. Barua, J. Grebely.
Obtaining of funding: S. Barua, L.E. Taylor.
Administrative, technical, or logistic support: S. Barua, J. Grebely, L.E. Taylor.
Collection and assembly of data: S. Barua, R. Greenwald, J. Grebely, L.E. Taylor.
The aim of this study was to systematically evaluate state Medicaid policies for the treatment of hepatitis C virus (HCV) infection with sofosbuvir in the United States. Medicaid reimbursement criteria for sofosbuvir were evaluated in all 50 states and the District of Columbia. The authors searched state Medicaid Web sites between 23 June and 7 December 2014 and extracted data in duplicate. Any differences were resolved by consensus. Data were extracted on whether sofosbuvir was covered and the criteria for coverage based on the following categories: liver disease stage, HIV co-infection, prescriber type, and drug or alcohol use. Of the 42 states with known Medicaid reimbursement criteria for sofosbuvir, 74% limit sofosbuvir access to persons with advanced fibrosis (Meta-Analysis of Histologic Data in Viral Hepatitis [METAVIR] fibrosis stage F3) or cirrhosis (F4). One quarter of states require persons co-infected with HCV and HIV to be receiving antiretroviral therapy or to have suppressed HIV RNA levels. Two thirds of states have restrictions based on prescriber type, and 88% include drug or alcohol use in their sofosbuvir eligibility criteria, with 50% requiring a period of abstinence and 64% requiring urine drug screening. Heterogeneity is present in Medicaid reimbursement criteria for sofosbuvir with respect to liver disease staging, HIV co-infection, prescriber type, and drug or alcohol use across the United States. Restrictions do not seem to conform with recommendations from professional organizations, such as the Infectious Diseases Society of America and the American Association for the Study of Liver Diseases. Current restrictions seem to violate federal Medicaid law, which requires states to cover drugs consistent with their U.S. Food and Drug Administration labels.
Table 1. State Eligibility/Ineligibility Criteria for Sofosbuvir Approval
Table 2. State Substance Use–Related Requirements for Sofosbuvir Approval
Medicaid reimbursement criteria for sofosbuvir based on documented liver fibrosis stage required for reimbursement.
METAVIR = Meta-Analysis of Histologic Data in Viral Hepatitis.
Medicaid reimbursement criteria for sofosbuvir based on the required period of abstinence from drug and alcohol use.
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In this video, Lynn E. Taylor, MD, and colleagues offer additional insight into their article, "Restrictions for Medicaid Reimbursement of Sofosbuvir for the Treatment of Hepatitis C Virus Infection in the United States."
Donald Venes, MD
July 4, 2015
Theory and Practice
The authors should be commended for their academic and legal analysis of sofosbuvir prescription limitations for Medicaid patients. In theory it would be ideal if every Hepatitis C patient received treatment without limits. In practice, however, if the authors' ideal were reached, a back-of-the-envelope calculation indicates that drug treatment for Americans with HCV would total ~$2.5 x 10 raised to the 11th power, prior to factoring in the cost of health care personnel (doctors, nurse, pharmacists, LVNs, laboratorians, administrators ...), buildings, labs, light, heat, power, training, re-training, refrigeration, etc. These sums would exceed the current Gross National Product of all but a handful of nations on earth. If HCV were treated according to the authors' ideal, money for education, eldercare, roads, other diseases, national defense, and every other social good would be zeroed out. The ideal society, in the authors' view, is one free of HCV infection but otherwise in shambles.
Colleen Flanigan RN MS, Bruce Agins MD MPH, Charles Gonzalez MD, Ira Feldman, Franklin Laufer PhD
New York State Department of Health, AIDS Institute, Albany, New York
July 30, 2015
Defining an experienced hepatitis C provider
TO THE EDITOR,Barua and colleagues (1) provide a comprehensive summary of the restrictions imposed by state Medicaid programs for access and reimbursement of Sofosbuvir treatment for hepatitis C virus (HCV) infection. The authors categorize New York State’s (NYS) Medicaid program as limiting Sofosbuvir prescribing solely to hepatologists, gastroenterologists, infectious disease or liver transplantation physicians. This information does not reflect the state’s current clinical criteria for prescribing Sofosbuvir. NYS’s Medicaid program posted its clinical criteria for Sofosbuvir in October 2014 (http://www.health.ny.gov/health_care/medicaid/program/dur/hepa_c_virus.htm). This may have occurred after the authors conducted their review of states’ criteria. Currently, NYS’s Medicaid program does not restrict HCV treatment prescribing to specialists. In fact, the NYS Department of Health AIDS Institute, along with its HCV Clinical Guidelines Committee, has developed criteria for defining “experienced HCV clinicians” to ensure that patients are being treated by clinicians with the appropriate level of expertise to deliver the necessary care to persons with HCV that meets current quality standards. The criteria consist of three components: clinical management, continuing education and licensure. Providers must meet all three criteria. Clinical experience and appropriate continuing education are both important to ensure that HCV medications are prescribed safely and correctly and that all patients receive the highest quality of care. These criteria have been adopted by the NYS Medicaid program and by most of the state’s Medicaid managed care plans. Additional information on the definition of an experienced HCV provider can be obtained by going to: http://www.hivguidelines.org/clinical-guidelines/hepatitis-c-virus-mono-infection/defining-the-experienced-hepatitis-c-provider/NYS has taken many steps to ensure access to these highly effective medications, including providing funding to primary care settings to integrate HCV care, treatment and supportive services; the development of guidelines for the management and treatment of HCV by primary care providers; and the derivation of HCV quality indicators. ReferencesBarua S, Greenwald R, Grebely J, Dore GJ, Swan T, Taylor LE. Restrictions for Medicaid reimbursement of Sofosbuvir for the treatment of Hepatitis C virus in the United States. Ann Intern Med. Published online 30 June 2015 doi:10.7326/M15-0406.
Barua S, Greenwald R, Grebely J, Dore GJ, Swan T, Taylor LE. Restrictions for Medicaid Reimbursement of Sofosbuvir for the Treatment of Hepatitis C Virus Infection in the United States. Ann Intern Med. ;163:215–223. doi: 10.7326/M15-0406
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Published: Ann Intern Med. 2015;163(3):215-223.
Gastroenterology/Hepatology, Healthcare Delivery and Policy, Infectious Disease, Liver Disease, Viral Hepatitis.
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